Evaluation of Rebamipide and Rabeprazole Effect Associated or Not to Prevent Naproxen-induced Gastric Lesions

PHASE3CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 12, 2014

Primary Completion Date

November 27, 2014

Study Completion Date

February 4, 2015

Conditions
Gastric Lesion
Interventions
DRUG

550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole.

Oral administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days.

DRUG

550 mg naproxen + placebo + 20 mg rabeprazole

Oral administration of 550 mg naproxen 2x daily + placebo of rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days.

DRUG

550 mg naproxen + 300 mg rebamipide + placebo

Oral administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + placebo of rabeprazole 1x daily over 7 days.

DRUG

550 mg naproxen + placebo + placebo

Oral administration of 550 mg naproxen 2x daily + placebo 2x daily + placebo of rabeprazole 1x daily over 7 days.

Trial Locations (1)

13087-010

Galeno Desenvolvimento de Pesquisas Clinicas Ltda., Campinas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Biolab Sanus Farmaceutica

INDUSTRY

lead

Galeno Desenvolvimento de Pesquisas Clínicas

OTHER_GOV